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Not yet recruitingNCT07802457Updated Sep 3, 2026

Diagnosis of Women With ANOCA

An observational study in Angina With No Obstructive Coronary Artery Disease, sponsored by NHS Greater Glasgow and Clyde. Not yet recruiting at 11 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by NHS Greater Glasgow and Clyde · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
Female
01

Study summary

Angina is a feeling of chest pain or discomfort which can happen if there is reduced blood flow to the heart. Patients can experience angina with no obstructive coronary arteries (ANOCA) which is a difficult condition to treat (ie relieve angina) since few randomised, controlled therapy trials have been undertaken for ANOCA.

Until now, angina has been mainly studied in men even though women are at least two-fold more likely than men to experience ANOCA.

Research studies involving people with ANOCA may have limitations in relation to retrospective collection of historical data or lack of prospectively collected contemporary data. These limitations are particularly relevant to women with ANOCA which is an area that has been historically under-recognised.

Prior studies may have data gaps, such as for women's health. For these reasons, the Investigators propose a research registry for women with ANOCA which aims to plug these gaps. The Investigators aim to understand the biological mechanisms behind angina in women specifically.

This study will categorise ANOCA into different subtypes and offer women the opportunity to take part in research studies to treat ANOCA. The Investigators will also follow the women's health over time through remote data collection methods.

Read the detailed description

There is a paucity of evidence of long term outcomes of women with ANOCA or understanding of the potentially unique mechanisms which could drive ANOCA in women specifically.

In order to understand the impact of ANOCA, and related endotypes, on an individual's wellbeing and the related healthcare needs, follow-up for vital status, episodes of care (primary and secondary care) and medication use is vital.

The availability of electronic health records in the NHS is enabling for this purpose and without the need to contact patients. Accordingly, in ANOCA Diagnosis, women will be followed up without requiring further visits post enrolment.

Furthermore, allowing endotyping of the ANOCA allows for targeted treatments. Women in this trial will be approached for participation in future research studies for potential new treatments for ANOCA.

02

Conditions studied

  • Angina With No Obstructive Coronary Artery Disease

Keywords

  • Angina
  • Cardiovascular disease
  • Cohort study
  • Endotype
  • Women
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include women of biological female sex with ANOCA and the participants should have a diagnosis of microvascular angina and/or vasospastic angina and an endotype defined by recent diagnostic tests within one year of enrolment.

Inclusion criteria

  • ANOCA endotype0
  • Myocardial perfusion reserve or coronary flow reserve recorded within one year
  • Seattle Angina Questionnaire frequency score \<100
  • Female sex

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years
  • Unable to provide informed consent
  • Unable to comply with the protocol
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
25 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cohort 1

    Women with ANOCA

05

What researchers measure

Primary outcomes

  1. Seattle Angina Questionnaire

    The Seattle Angina Questionnaire a validated 19-item patient-reported survey used to measure coronary artery disease and angina treatment efficacy. Patients will complete on paper or electronically. The scores range from 0 to 100, with higher scores indicating less frequent angina, improved function, and better quality of life

    Time frame: Enrolment

Secondary outcomes

  1. Brief Illness perception Questionnaire (Brief IPQ)

    A nine-item scale designed to rapidly assess the cognitive and emotional representations of illness. It consists of 9 items: 8 are scored on a 0-10 scale, and item 9 is an open-ended question assessing perceived causes. The total score (0-80) is calculated by summing the first 8 items, with items 3, 4, and 7 reverse scored. Higher scores generally reflect a more threatening perception of the illness

    Time frame: Enrolment

  2. Patient Health Questionnaire-4 of (PHQ4)

    An ultra-brief screening tool used to assess core symptoms of anxiety and depression. Higher scores indicate greater feelings of anxiety and depression.

    Time frame: Enrolment

  3. Duke Activity Status Index (DASI)

    A 12-item, self-administered questionnaire used to estimate a patient's functional capacity and peak oxygen uptake. Scores range from 0 to 58.2, with higher scores indicating better physical fitness and lower risk

    Time frame: Enrolment

  4. EQ-5D (EQ-5D-5L)

    The EQ-5D evaluates health across 5 domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). It yields three metrics: a 5-digit health profile string, a weighted index value, and a 0-100 self-rated Visual Analogue Scale (VAS) score. For the 5-digit health profile string higher individual numbers indicate worse health problems. For the weighted index value a score of 1 indicates perfect health, while 0 represents death. For the visual analogue score higher numbers here indicate better health

    Time frame: Enrolment

  5. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Measures patient satisfaction with their prescription medications. It evaluates core aspects of a patient's treatment experience, including effectiveness, side effects, convenience, and overall satisfaction. Individual item scores within each domain are summed and transformed into a standardized scale from 0 to 100, where higher scores mean greater treatment satisfaction

    Time frame: Enrolment

  6. The Montreal Cognitive Assessment (MoCA)

    30-point medical screening test used by health professionals to detect early signs of mild cognitive impairment and dementia. It covers domains such as memory, visuospatial awareness, executive function, attention, language and orientation to place and time. Higher scores indicate better cognitive function with scores 30-26 indicating normal function, 25-18 indicating mild cognitive impairment and below 18 indicating potential thinking and memory problems.

    Time frame: Enrolment

  7. Sex specific cardiovascular risk score - Heart age score

    Heart age score can indicate chance of having a heart attack, stroke or developing heart disease. It uses height, weight, blood pressure, cholesterol levels and family history of disease to calculate a heart age. If the age of participant's heart is older than their actual age, they are at higher risk for developing a heart condition. The investigators want to understand if women have sex specific risks.

    Time frame: Across 25 years

  8. Sex specific cardiovascular risk score - QRisk score

    QRISK is a calculation to estimate participants' risk of developing cardiovascular disease over the next 10 years. It uses information such as age, sex, ethnic background, where participants live, smoking status, weight, existing medical conditions, family history and blood pressure to calculate a score. A score of less than 10% indicates low risk, 10-20% indicates moderate risk and 20% or higher indicates higher risk of developing heart disease over the next 10 years. The investigators want to understand if women have sex specific risks.

    Time frame: Across 25 years

  9. Sex specific cardiovascular risk score - EuroSCORE II

    EuroSCORE II a risk assessment tool that estimates the percentage risk of dying during or shortly after major heart surgery. It uses patient related factors such as age, gender, presence of chronic kidney disease, diabetes and poor mobility. Cardiac related factors such as presence of recent heart attack, how well the heart pumps blood and pulmonary hypertension (high blood pressure in the arteries that carry blood from your heart to your lungs), and operation related factors such as how urgent the procedure is. The final score is expressed as a percentage representing the predicted probability of dying in hospital. Scores under 2% represent low predicted risk, Scores between 2% and 5% reflect a moderate risk level and scores of 6% or higher place a patient in a higher-risk category, where the complexity or underlying conditions significantly elevate risk. The investigators want to understand if women have sex specific risks.

    Time frame: Across 25 years

  10. Dementia risk score

    We will use UK Biobank Dementia Risk Score (UKBDRS) to understand participant's risk of dementia. Items such as age, education, smoking history and medication use are considered to give a score. Higher scores describes a higher probability of dementia within the next 14 years but is not a clinical diagnosis.

    Time frame: Baseline

  11. Episodes of care

    We will record how often the participants see their medical providers and for which reason

    Time frame: Over 25 years

06

Study locations

11 sites
  • Essex cardiothoracic centre
    Basildon, United Kingdom
  • Royal United Hospital Bath
    Bath, United Kingdom
  • Royal Papworth Hospital
    Cambridge, United Kingdom
  • Queen Elizabeth University Hospital Clinical Research Facility,
    Glasgow, G51 4TF, United Kingdom
  • Leeds General Infirmary
    Leeds, United Kingdom
  • Brompton Hospital
    London, United Kingdom
  • Guys and St Thomas Hospital
    London, United Kingdom
  • Kings college london
    London, United Kingdom
  • Freeman Hospital
    Newcastle upon Tyne, United Kingdom
  • Nottingham City Hospital
    Nottingham, United Kingdom
  • Sunderland Royal Hospital
    Sunderland, United Kingdom
07

References and documents

Individual participant data

Plan to share: Yes — A decision will be made by the TSC once the study has ended.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07802457
Lead sponsor
NHS Greater Glasgow and Clyde
Collaborators
The University of Glasgow
Responsible party
Sponsor
First posted
Sep 3, 2026
Start date
Nov 27, 2026 (estimated)
Primary completion
Dec 30, 2028 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Sep 3, 2026

Study contacts

Clare Dolan
Contact
clare.dolan3@nhs.scot
0141 314 4328
PMU Mail box
Contact
ggc.pmu.research@nhs.scot
0141 314 4328
Colin Berry, PhD
principal investigator · The University of Glasgow

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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